ABILIFY(R) (Aripiprazole) Demonstrated Efficacy as Maintenance Therapy In Adults with Bipolar I Disorder Following Treatment for a Recent Manic or Mixed Episode.

- Study in Journal of Clinical Psychiatry Shows ABILIFY Significantly Delayed the Time to Manic Relapse -

PRINCETON, N.J. and TOKYO, May 16 /PRNewswire-FirstCall/ -- Maintenance therapy with the Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. atypical antipsychotic ABILIFY(R) (aripiprazole) significantly delayed the time to relapse in adults with Bipolar I Disorder who had been stabilized and maintained on ABILIFY for at least six weeks, according to findings of a randomized, double-blind placebo-controlled study of patients with a recent manic or mixed episode published in the current issue of the Journal of Clinical Psychiatry.(1) These study results were based on rigorous criteria used to define stability for Bipolar I Disorder.

"These findings are important because Bipolar I Disorder is a lifelong episodic illness and an important goal of treatment is to prevent or delay recurrent mood symptoms," said lead investigator Paul E. Keck, Jr., M.D., professor of psychiatry and pharmacology and vice chairman for research, Department Of Psychiatry, University Of Cincinnati College Of Medicine. "Up to 40 percent of adults who respond to initial treatment have relapses within one year,(2),(3) emphasizing the need for maintenance treatment."

Bipolar I Disorder can be treated with antipsychotic medications.(4) ABILIFY is one of only two atypical antipsychotics indicated for maintenance therapy in Bipolar I Disorder. ABILIFY(R) (aripiprazole) is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks. Physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual.

Study Design and Findings

In the study, adults with Bipolar I Disorder who had recently been hospitalized and treated for a manic or mixed episode were initially stabilized with ABILIFY monotherapy (15 or 30 mg/day for 6-18…